Biostatistical Programming Associate **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us. **Statistical Programming Associate** **What you will do** Let's do this. Let's change the world. Amgen is expanding its Global Statistical Programming capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As a Biostatistical Programming Associate, you will perform hands on statistical programming activities to support statistical data analysis of phase 1 to 4 clinical studies and regulatory submissions. **Responsibilities:** + Analysis and reporting of clinical trial data using SAS and/or R + Creation and validation of SDTM, ADaM, and other analysis datasets, both safety and efficacy + Creation and validation of tables, listings, and figures, both safety and efficacy + Maintain tracking and validation documentation + Collaborate with cross-functional team and create and/or validate programs for checking data quality + Interact and collaborate with study team members from other functions globally This position will be located at Amgen India (Hyderabad). **Win** **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a results-oriented, tech-forward programming leader with deep expertise in clinical trial operations and digital transformation.



Basic Qualifications: + BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 3 years of statistical programming experience in clinical development environment. + Familiarity with drug development life cycle and excellent skills with manipulation, analysis and reporting of clinical trials data + Ability to provide quality output and deliverables, in adherence with challenging timelines + Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners + Ability to work effectively on multiple tasks or projects + Working knowledge of latest CDISC SDTM standards and familiar with CDISC ADaM and Define standards, with ability to implement the standards + Familiar with data quality and compliance check tools + Excellent oral and written English communication skills Preferred Skills: + MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects + Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming + In depth knowledge of SAS/STAT packages + Prior regulatory submission experience **Thrive** **What you can expect of us** As we work to develop treatments that take care of others, so we work to care for our teammates' skilled and personal growth and well-being. + Vast opportunities to learn and move up and across our global organization + Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act + Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

📌 Biostatistical Programming Associate (Hyderabad)
🏢 AMGEN
📍 Hyderabad